SurgeryNCT05097066
Patterns and Outcomes of Neurosurgery in England Over a Five-year Period
An observational study of Surgery and Surgery--Complications, run by University of Leeds.
Trial summary
Neurosurgical practice has seen many important changes over several decades with advances in treatments and the types of patients treated. Neurosurgical procedures have evolved, and as outcomes have improved the number of patients being treated has increased. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Surgery--Complications, Neurological Morbidity
- What is being tested?
- Neurosurgical procedure
- Type of treatment
- Surgery or procedure
- How many people
- 371,418 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All admissions to neurosurgical units in the National Health Service (NHS) in England. This covers any patients in England who required neurosurgical care, except those admitted to Private Providers of neurosurgical care.
Who may be able to join
- All admissions to neurosurgical units in the National Health Service (NHS) in England.
Who cannot join
- Records with poor quality data (e.g. no data for clinical diagnoses).
- Patients under 18 years that were admitted to an adult neurosurgical unit.
About this study
Official title: Patterns and Outcomes of Neurosurgery in England Over a Five-year Period: a National Retrospective Cohort Study
Neurosurgical practice has seen many important changes over several decades with advances in treatments and the types of patients treated. Neurosurgical procedures have evolved, and as outcomes have improved the number of patients being treated has increased.
There are no recent evaluations of national neurosurgical practice in the United Kingdom (UK), with the last prospective cohort studies being Safe Neurosurgery 1993 and Safe Neurosurgery 2000. More recent studies of neurosurgical services have been based on data from single institutions or surgeons and these may not give a representative picture of practice nationally.
Read more
Recent national quality improvement programmes for neurosurgery in England (such as the National Neurosurgical Audit Programme (NNAP) and Cranial Neurosurgery and Spinal Surgery Getting It Right First Time (GIRFT) Programmes) have focused on using national hospital administrative datasets. To be effective, quality improvement initiatives require robust outcome measures and quality (process) indicators. Currently, there is a lack of validated quality indicators for neurosurgery, with practice often being described using generic measures such as readmission and reoperation rates and length of stay. Many studies have been able to derive these common outcome measures, but it may also be possible to produce indicators specific to neurosurgery.
The aim of this observational study was firstly to describe the current pattern of neurosurgical admissions and procedures in England, and thereby given an overview of the epidemiology of neurosurgical patients. Secondly, it aims to investigate the range of outcome measures that might be produced from hospital administrative data and use these to assess the quality of care in neurosurgery.
- Conditions
- Surgery, Surgery--Complications, Neurological Morbidity, Neurological Diseases or Conditions, Neurological Disorder, Neurological Complication
- Being tested
- Neurosurgical procedure
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurosurgical procedureProcedure or surgery
Any neurosurgical procedure in the National Neurosurgical Audit Programme (NNAP) Coding Framework of neurosurgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Elective neurosurgery | Any elective neurosurgical procedure. Receives: Procedure: Neurosurgical procedure | |
| Non-elective neurosurgery | Any non-elective neurosurgical procedure. Receives: Procedure: Neurosurgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Length of the hospital admission to neurosurgery
Measured: From date of admission to date of discharge from hospital; assessed up to 60 months.
Additional inpatient neurosurgical procedure rate
A further neurosurgical procedure in admissions where patients have had a primary (main) neurosurgical procedure.
Measured: From date of admission to date of discharge from hospital; assessed up to 60 months.
Proportion of patients discharged home
Proportion of patients discharged to their normal address.
Measured: Determined on date of discharge from hospital; assessed up to 60 months.
In-patient mortality rate
In-patient mortality after a neurosurgical procedure.
Measured: From date of the neurosurgical procedure through date of death from any cause (in-patient deaths only); assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Apr 2013
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 371,418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Surgeons of England
- Responsible party
- Principal investigator, Ryan Mathew, University of Leeds
- Investigators
- Ryan Mathew, Study chair, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097066
- Sponsor's protocol ID
- NNAP002
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns and Outcomes of Neurosurgery in England Over a Five-year Period: a National Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05097066
- Acronym / sponsor ID
- NNAP002
- Conditions
- Surgery, Surgery--Complications, Neurological Morbidity, Neurological Diseases or Conditions, Neurological Disorder, Neurological Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371,418 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Royal College of Surgeons of England
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurosurgical practice has seen many important changes over several decades with advances in treatments and the types of patients treated. Neurosurgical procedures have evolved, and as outcomes have improved the number of patients being treated has increased.
There are no recent evaluations of national neurosurgical practice in the United Kingdom (UK), with the last prospective cohort studies being Safe Neurosurgery 1993 and Safe Neurosurgery 2000. More recent studies of neurosurgical services have been based on data from single institutions or surgeons and these may not give a representative picture of practice nationally.
Recent national quality improvement programmes for neurosurgery in England (such as the National Neurosurgical Audit Programme (NNAP) and Cranial Neurosurgery and Spinal Surgery Getting It Right First Time (GIRFT) Programmes) have focused on using national hospital administrative datasets. To be effective, quality improvement initiatives require robust outcome measures and quality (process) indicators. Currently, there is a lack of validated quality indicators for neurosurgery, with practice often being described using generic measures such as readmission and reoperation rates and length of stay. Many studies have been able to derive these common outcome measures, but it may also be possible to produce indicators specific to neurosurgery.
The aim of this observational study was firstly to describe the current pattern of neurosurgical admissions and procedures in England, and thereby given an overview of the epidemiology of neurosurgical patients. Secondly, it aims to investigate the range of outcome measures that might be produced from hospital administrative data and use these to assess the quality of care in neurosurgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective neurosurgery | – | Procedure: Neurosurgical procedureAny elective neurosurgical procedure. |
| Non-elective neurosurgery | – | Procedure: Neurosurgical procedureAny non-elective neurosurgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All admissions to neurosurgical units in the National Health Service (NHS) in England. This covers any patients in England who required neurosurgical care, except those admitted to Private Providers of neurosurgical care.
Key inclusion criteria (1 listed)
- All admissions to neurosurgical units in the National Health Service (NHS) in England.
Key exclusion criteria (2 listed)
- Records with poor quality data (e.g. no data for clinical diagnoses).
- Patients under 18 years that were admitted to an adult neurosurgical unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurosurgical procedureAny neurosurgical procedure in the National Neurosurgical Audit Programme (NNAP) Coding Framework of neurosurgical procedures. | Procedure or surgery | Elective neurosurgery, Non-elective neurosurgery |
Primary outcome
Length of stay
Time frame: From date of admission to date of discharge from hospital; assessed up to 60 months.
Length of the hospital admission to neurosurgery
Additional inpatient neurosurgical procedure rate
Time frame: From date of admission to date of discharge from hospital; assessed up to 60 months.
A further neurosurgical procedure in admissions where patients have had a primary (main) neurosurgical procedure.
Proportion of patients discharged home
Time frame: Determined on date of discharge from hospital; assessed up to 60 months.
Proportion of patients discharged to their normal address.
In-patient mortality rate
Time frame: From date of the neurosurgical procedure through date of death from any cause (in-patient deaths only); assessed up to 60 months.
In-patient mortality after a neurosurgical procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Mathew study chair
University of Leeds
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Surgery--Complications, run by University of Leeds.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: From date of admission to date of discharge from hospital; assessed up to 60 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.